Progesterone Variation on the Final Day of Oocyte Maturation.
1 other identifier
observational
22
1 country
1
Brief Summary
The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2018
CompletedApril 4, 2018
April 1, 2018
3 months
November 28, 2017
April 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progesterone variation among 4 different moments on the day of ovulation triggering
Measurement of serum Progesterone (ng/ml) in each oocyte donor at 4 different times on the day of ovulation triggering: The primary outcome will be the variation among the 4 progesterone measurements for each patient within the fixed12 hours time (8:00am; 12:00pm; 4:00pm and 8:00pm).
Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm
Study Arms (1)
Oocyte donors
Healthy oocyte donors undergoing ovarian stimulation with recombinant Follicular stimulating hormone
Interventions
Serum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm
Eligibility Criteria
Healthy oocyte donors according to spanish law for oocyte donation
You may qualify if:
- Healthy oocyte donors according to spanish law for oocyte donation
- Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone.
- Informed consent signed
You may not qualify if:
- Detection of luteinizing hormone surge before triggering
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion Dexeuslead
Study Sites (1)
Salud de la Mujer Dexeus
Barcelona, 08028, Spain
Related Publications (1)
Gonzalez-Foruria I, Rodriguez I, Martinez F, Rodriguez-Purata J, Montoya P, Rodriguez D, Nicolau J, Coroleu B, Barri PN, Polyzos NP. Clinically significant intra-day variability of serum progesterone levels during the final day of oocyte maturation: a prospective study with repeated measurements. Hum Reprod. 2019 Aug 1;34(8):1551-1558. doi: 10.1093/humrep/dez091.
PMID: 31334546DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 8, 2017
Study Start
November 1, 2017
Primary Completion
January 25, 2018
Study Completion
January 25, 2018
Last Updated
April 4, 2018
Record last verified: 2018-04